For those who wish they had gotten in on the ground floor of companies such as Apple or Google, a London scientist has thrown open the door to investors in what he believes will be the world’s first vaccine for HIV.

Chil-Yong Kang has cleared a major hurdle for his vaccine, showing it to be safe and potentially effective in a clinical trial involving a few dozen people.

But the next two phases to seek regulatory approval will prove costly — he estimates roughly $100 million.

While the Korean drug company that has backed the vaccine, Sumagen Co. Ltd., is seeking a multinational partner, Kang says now is the time for smaller and mid-sized players to get in, too — before a Phase 2 trial moves the vaccine a step closer.

“The price will go up as we complete Phase 2,” he said Tuesday.

A scientist at Western University’s Schulich School of Medicine and Dentistry, Kang began his search for a vaccine two decades ago and has followed the path less taken.

Other HIV vaccines are based on fragments of virus, an approach Kang says has fallen short. He uses a whole virus, as is done for polio, rabies, influenza and hepatitis A, an approach others thought would prove unsafe or impossible to make in large quantities — obstacles he believes he has overcome with chemicals, gamma rays and genetic modifications.

His Korean backer agrees: “Sumagen anticipates not only having the first HIV vaccine in market, but also the eradication of HIV/AIDS for human beings.”

But Sumagen lacks the high-security lab needed to make the vaccine and the deep pockets to take on the risk of development on its own.

“We are opening the gate to pharmaceutical companies, government, and charity organization for collaboration to be one step closer to the first commercialized HIV vaccine,” wrote Jung-Gee Cho, chief executive of Sumagen.

Only four independent labs in the world are deemed secure enough by American regulators to make the vaccine, Kang said, and the one used for the first clinical trial in Bethesda, Md., is too small to do the other phases.

One of two labs in Europe is prepared to do the second phase, but only a multinational drug company will have the capacity to do the last phase, involving thousands of patients, Kang said.

Before Kang can seek American approval to conduct the next phase, the European lab must be able to make the vaccine in a way that meets 230 different tests for safety.

“Hopefully in less than a year,” he said.

He said he hopes it proves as successful as the first phase, which found no significant adverse effects and boosted antibodies against HIV many-fold.

That’s encouraging, said Graig Suvannavejh, senior biotech analyst with MLV Co. in New York. But the road ahead has been a perilous one for others, even major multinationals such as Merck.

“There is a graveyard of HIV candidates,” he said.

Also, in the time since Kang began his research, HIV has gone from being a death sentence to a treatable disease, one for which big drug companies sell $5 billion a year.

--- --- ---

CLINICAL TRIALS PRIMER

Drug Trials are done in phases, each with a different purpose, that move a new drug toward approval:

Phase 1: Evaluate safety and side effects in 20 to 80 people.

Phase 2: Measure effect, safety for 100 to 300 people.

Phase 3: Confirm effectiveness, monitor side effects for 1,000 to 3,000 people, compare with equivalent treatments. After this stage, a drug may be approved for use.